Intermediate Endpoint Proposals For Cancer Immunotherapies Don’t Sway FDA
An issue brief laying out four potential intermediate endpoints for checkpoint modulators draws a cautious response from FDA representatives at a cancer research conference. The endpoints may prove useful for exploratory purposes but are far from ready to serve as the basis for registration, agency says.
You may also be interested in...
Bristol-Myers Squibb's immunotherapy Yervoy (ipilimumab) will enter the market positioned for wide use, with a broad label for its approval for metastatic melanoma and positive Phase III results for front-line patients.
Failure casts doubt on Bristol/Medarex’s CTLA-4 inhibitor ipilimumab, analysts say.
Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.